Overview
EN ISO 10993-10:2023 (ISO 10993-10:2021) - Biological evaluation of medical devices - Part 10: Tests for skin sensitization - specifies procedures for assessing whether medical devices or their constituent materials can induce skin sensitization. The standard focuses on in vivo test methods and key factors for interpreting results, with instructions for material preparation provided in Annex A. It is part of the ISO 10993 series used for biocompatibility and supports conformity to EU regulatory requirements (Regulation (EU) 2017/745) when applied with related parts of the series.
Key topics
- Scope and step-wise approach: A risk-based, progressive testing strategy to determine need and type of skin sensitization testing.
- Pretest considerations: Guidance on information collection (chemical composition, existing data), and material-specific issues for ceramics, metals and alloys, polymers, and biologically derived materials.
- In vivo test methods:
- Murine Local Lymph Node Assay (LLNA) - principle, sample preparation, animals and husbandry, test procedure, treatment groups, measurement of lymph node cellular proliferation, data interpretation and reporting.
- Guinea pig assays - principles, induction and challenge phases, selection of test concentrations and interpretation.
- Important variables: Material preparation, sample extraction, concentration selection, animal welfare and husbandry, and analytical endpoints that affect test outcomes.
- Reporting and interpretation: Criteria for results, documentation requirements and how to integrate findings into biological evaluation and risk management.
- Regulatory alignment: Annex ZA explains how EN ISO 10993-10 aligns with General Safety and Performance Requirements of the EU Medical Device Regulation (MDR).
Applications
Who uses EN ISO 10993-10:2023:
- Medical device manufacturers conducting biocompatibility testing and safety evaluations.
- Contract testing laboratories performing skin sensitization tests (LLNA and guinea pig assays).
- Regulatory affairs and quality teams preparing technical documentation and addressing EU MDR requirements.
- Notified bodies and clinical safety assessors reviewing device safety and risk management files.
- R&D teams selecting materials and designing preclinical safety strategies.
Practical uses:
- Determining whether device materials or residuals pose a sensitization risk.
- Designing test plans, preparing samples (per Annex A), and interpreting in vivo assay results.
- Supporting premarket submissions and post-market safety assessments.
Related standards
Keywords: EN ISO 10993-10:2023, ISO 10993-10, skin sensitization, biological evaluation, medical devices, LLNA, guinea pig assay, EU MDR.
